MAUDE Adverse Event Report: VAPOTHERM, INC. VAPOTHERM; HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE

Device Problems Insufficient Flow or Under Infusion (2182); Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/13/2020

Event Type  malfunction  

Event Description

Vapotherm precision flow shut off, and was flashing indicating that o2 (oxygen % display) sensor failed.The temperature display was also flashing with a temperature of 52.Staff unplugged the device from the power outlet, and plugged back in.The device continued doing the same thing, and o2 saturations decreased this time.The equipment was replaced afterwards.

• Brand Name: VAPOTHERM
• Type of Device: HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): VAPOTHERM, INC.; 100 domain dr; exeter NH 03833
• MDR Report Key: 10086640
• MDR Text Key: 191997285
• Report Number: 10086640
• Device Sequence Number: 1
• Product Code: QAV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8395 DA